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List of Drug Master Files (DMF) of Gemfibrozil Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
26/09/2024 PMC Isochem
France
ISOCHEM SAS 18056 GEMFIBROZIL 2005-02-03 Active II N/A
26/09/2024 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 19454 GEMFIBROZIL USP 2006-05-22 Active II N/A